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MITOTANE

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Overview

What is LYSODREN?

LYSODREN (mitotane) is an oral adrenal cytotoxic agent. The chemical name is (±)-1,1-dichloro-2-(-chlorophenyl)-2-(-chlorophenyl) ethane (also known as o,p′-DDD). The chemical structure is:

Mitotane is a white granular solid composed of clear colorless crystals. It is tasteless and has a slight pleasant aromatic odor. It is soluble in ethanol and has a molecular weight of 320.05.

Inactive ingredients in LYSODREN are: microcrystalline cellulose, polyethylene glycol 3350, silicon dioxide, and starch.



What does LYSODREN look like?



What are the available doses of LYSODREN?

Tablets: 500 mg, scored

What should I talk to my health care provider before I take LYSODREN?

How should I use LYSODREN?

LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma.

The recommended initial dose of LYSODREN is 2 g to 6 g orally, in three or four divided doses per day. Increase doses incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated.

LYSODREN is a cytotoxic drug. Follow applicable special handling and disposal procedures.


What interacts with LYSODREN?

Sorry No Records found


What are the warnings of LYSODREN?

Sorry No Records found


What are the precautions of LYSODREN?

Sorry No Records found


What are the side effects of LYSODREN?

Sorry No records found


What should I look out for while using LYSODREN?

None.


What might happen if I take too much LYSODREN?

Sorry No Records found


How should I store and handle LYSODREN?

Dispense in a tight container as defined in the USP with a child-resistant closure.LYSODREN tablets are supplied as 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with “BL” over “L1” on the other side.100 tablets per bottle: NDC 0015-3080-60Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F).Mitotane is a cytotoxic drug. Follow applicable special handling and disposal procedures .LYSODREN tablets are supplied as 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with “BL” over “L1” on the other side.100 tablets per bottle: NDC 0015-3080-60Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F).Mitotane is a cytotoxic drug. Follow applicable special handling and disposal procedures .LYSODREN tablets are supplied as 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with “BL” over “L1” on the other side.100 tablets per bottle: NDC 0015-3080-60Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F).Mitotane is a cytotoxic drug. Follow applicable special handling and disposal procedures .LYSODREN tablets are supplied as 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with “BL” over “L1” on the other side.100 tablets per bottle: NDC 0015-3080-60Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F).Mitotane is a cytotoxic drug. Follow applicable special handling and disposal procedures .


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Mitotane is an adrenal cytotoxic agent with an unknown mechanism of action. Mitotane modifies the peripheral metabolism of steroids and directly suppresses the adrenal cortex. A reduction in 17-hydroxycorticosteroids in the absence of decreased corticosteroid concentrations and increased formation of 6-β-hydroxycortisol have been reported.

Non-Clinical Toxicology
None.

The benzodiazepines, including lorazepam, produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.

Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.

Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate.

Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.

The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation.

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

In patients taking LYSODREN, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock, and discontinue LYSODREN until recovery

The following adverse reactions are discussed in greater detail in other sections of the label:

•  Adrenal Crisis in the Setting of Shock or Severe Trauma

•   CNS Toxicity

•   Adrenal Insufficiency [ ]

The following adverse reactions associated with the use of LYSODREN were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Common adverse reactions occurring with LYSODREN treatment include:

•Anorexia, nausea, vomiting, and diarrhea (80%)

•Depression, dizziness, or vertigo (15%-40%)

•Rash (15%)•Neutropenia•Growth retardation, hypothyroidism

•Confusion, headache, ataxia, mental impairment, weakness, dysarthria

•Maculopathy•Hepatitis, elevation of liver enzymes•Gynecomastia

•   Hypercholesterolemia, hypertriglyceridemia

• Decreased blood androstenedione and decreased blood testosterone in females, increased sex hormone binding globulin in females      and males, decreased blood free testosterone in males.

Less common adverse reactions include: visual blurring, diplopia, lens opacity, retinopathy, prolonged bleeding time, hematuria, hemorrhagic cystitis, albuminuria, hypertension, orthostatic hypotension, flushing, generalized aching, and fever.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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